title: Self-Reported quality of life in adults with attention-deficit/hyperactivity disorder and executive function impairment treated with lisdexamfetamine dimesylate: a randomized, double-blind, multicenter, placebo-controlled, parallel-group study.
abstract: BACKGROUND
  This study examined the effects of lisdexamfetamine dimesylate (LDX) on quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) and clinically significant executive function deficits (EFD).
  
  
  METHODS
  This report highlights QOL findings from a 10-week randomized placebo-controlled trial of LDX (30-70 mg/d) in adults (18-55 years) with ADHD and EFD (Behavior Rating Inventory of EF-Adult, Global Executive Composite [BRIEF-A GEC] ≥65). The primary efficacy measure was the self-reported BRIEF-A; a key secondary measure was self-reported QOL on the Adult ADHD Impact Module (AIM-A). The clinician-completed ADHD Rating Scale version IV (ADHD-RS-IV) with adult prompts and Clinical Global Impressions-Severity (CGI-S) were also employed. The Adult ADHD QoL (AAQoL) was added while the study was in progress. A post hoc analysis examined the subgroup having evaluable results from both AIM-A and AAQoL.
  
  
  RESULTS
  Of 161 randomized (placebo, 81; LDX, 80), 159 were included in the safety population. LDX improved AIM-A multi-item domain scores versus placebo; LS mean difference for Performance and Daily Functioning was 21.6 (ES, 0.93, P<.0001); Impact of Symptoms: Daily Interference was 14.9 (ES, 0.62, P<.0001); Impact of Symptoms: Bother/Concern was 13.5 (ES, 0.57, P=.0003); Relationships/Communication was 7.8 (ES, 0.31, P=.0302); Living With ADHD was 9.1 (ES, 0.79, P<.0001); and General Well-Being was 10.8 (ES, 0.70, P<.0001). AAQoL LS mean difference for total score was 21.0; for subscale: Life Productivity was 21.0; Psychological Health was 12.1; Life Outlook was 12.5; and Relationships was 7.3. In a post hoc analysis of participants with both AIM-A and AAQoL scores, AIM-A multi-item subgroup analysis scores numerically improved with LDX, with smaller difference for Impact of Symptoms: Daily Interference. The safety profile of LDX was consistent with amphetamine use in previous studies.
  
  
  CONCLUSIONS
  Overall, adults with ADHD/EFD exhibited self-reported improvement on QOL, using the AIM-A and AAQoL scales in line with medium/large ES; these improvements were paralleled by improvements in EF and ADHD symptoms. The safety profile of LDX was similar to previous studies.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01101022.
authors.affiliation: Department of Psychiatry and Child and Adolescent Psychiatry, New York University School of Medicine and Psychiatry Service, New York VA Harbor Healthcare System, New York, NY, USA. Lenard.Adler@nyumc.org.
authors.forename: Lenard A
authors.initials: LA
authors.lastname: Adler
authors.forename: Bryan
authors.initials: B
authors.lastname: Dirks
authors.forename: Patrick
authors.initials: P
authors.lastname: Deas
authors.forename: Aparna
authors.initials: A
authors.lastname: Raychaudhuri
authors.forename: Matthew
authors.initials: M
authors.lastname: Dauphin
authors.forename: Keith
authors.initials: K
authors.lastname: Saylor
authors.forename: Richard
authors.initials: R
authors.lastname: Weisler
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology; D000328:Adult; D001288:Attention / Q000187:drug effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology*; D000697:Central Nervous System Stimulants / Q000494:pharmacology / Q000627:therapeutic use*; D003913:Dextroamphetamine / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D056344:Executive Function / Q000187:drug effects*; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D009483:Neuropsychological Tests; D011788:Quality of Life / Q000523:psychology*; D057566:Self Report; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine